NCT00801203已完成2 期
A Phase II/III Controlled Study to Evaluate the Effectiveness of the Induced Reflex Cough Test Plus Urodynamics to Identify Stress Urinary Incontinence in Female Subjects With a History of Stress Urinary Incontinence
Pneumoflex Systems, LLC10 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2008年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 10
- 主要终点
- Sensitivity to identify SUI in women with a history of SUI and specificity to not identify SUI in healthy women without a history of SUI
研究概览
简要总结
This study is to evaluate the effectiveness of identifying stress urinary incontinence (SUI) in female subjects using the Induced Reflex Cough Test (IRCT) administered with urodynamic testing by evaluation of sensitivity and specificity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women >25 years of age
- •History of SUI (except for healthy controls)
- •Healthy or stable medical problems (no change in 3 months)
- •Willingness and ability to undergo all the study procedures
- •Stable medications are allowed except for prescription and over-the-counter medications with anticholinergic or α-agonistic properties that can affect the bladder or urethra; these must be discontinued at least 2 weeks prior to evaluation
- •Able to understand and sign the informed consent document.
排除标准
- •Body mass index (BMI) >40
- •History of severe arthritis of the hips, knees, or feet that could limit mobility during the study
- •Prior treatment of any kind (surgical or pharmacologic) for incontinence at least 30 days before the cough testing session including treatment with slings, botox, interstim and all bulking agents
- •Prior pelvic radiation
- •Post-void residual urine >100 mL at screening
- •Pelvic Organ Prolapse Quantification (POP-Q) stage >2
- •Positive urine culture at screening or dip stick for >1+ leukocyte esterase on the day of the procedures
- •Positive pregnancy test
- •Evidence of infection with hepatitis or human immunodeficiency virus (HIV)
- •Clinically significant changes on the electrocardiogram (ECG) in women >50 years of age or in the clinical laboratory values as determined by the investigator
- •History of urge symptoms, diagnosis of interstitial cystitis, irritable bowel disease (requiring medications)
- •History of neurological deficit or injury that could affect laryngeal cough reflex, for example, central nervous system related conditions such as stroke or multiple sclerosis, head and neck cancer, major laryngeal surgery
- •History of neurological disorders leading to bladder abnormalities including stroke, Parkinsonism, multiple sclerosis, spinal cord surgery or spinal cord injury
- •Active hemorrhoids or history of recent (within 1 year) rectal surgery
- •Previous major pelvic or abdominal surgery (within 6 months)
- •Tobacco smokers and non-smokers who have >15 pack-year history or frequent (>2 times per week) marijuana smoking
- •Active sexually transmitted disease or genital herpes outbreak or symptomatic pelvic inflammatory disease
- •Pessary in place
研究组 & 干预措施
1
Experimental
Induced Reflex Cough Test (IRCT) followed by Voluntary Cough Test (VCT)
干预措施: IRCT (Drug)
2
Experimental
Voluntary Cough Test (VCT) followed by Induced Reflex Cough Test (IRCT)
干预措施: IRCT (Drug)
结局指标
主要结局
Sensitivity to identify SUI in women with a history of SUI and specificity to not identify SUI in healthy women without a history of SUI
时间窗: Study Day 1
次要结局
- Positive predictive value (PPV) and negative predictive value (NPV) of the IRCT administered with urodynamic testing(Study Day 1)
- Urodynamic parameters after IRCT and VCT in normal healthy women and women with a history of SUI(Study Day 1)
研究者
研究点 (10)
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